Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage

Treatments: Drug: Sodium Bicarbonate Powder and ondansetron; Drug: N-acetyl cysteine; Drug: medicated paraffin oil; Dietary Supplement: acetyl L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT04509258

R 66/2019

Details and patient eligibility

About

Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study

Exclusion criteria

1. Patients less than 18
2. Patients presented with delay time exceeding 12 hours after acute intoxication.
3. Patients with history of cardiac, renal or hepatic diseases.
4. Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines

Treatment:

Drug: Sodium Bicarbonate Powder and ondansetron

N- acetyl cysteine grouo

Active Comparator group

Description:

N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines

Treatment:

Drug: N-acetyl cysteine

Drug: Sodium Bicarbonate Powder and ondansetron

Acetyl L-carnitine group

Active Comparator group

Description:

Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided

Treatment:

Dietary Supplement: acetyl L-carnitine

Drug: Sodium Bicarbonate Powder and ondansetron

Medicated paraffin oil group

Active Comparator group

Description:

Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines

Treatment:

Drug: medicated paraffin oil

Drug: Sodium Bicarbonate Powder and ondansetron